Kornimate/medical-research-clean huggingface dataset:
study of the efficacy, safety, and tolerability of serlopitant for pruritus (itch) in atopic dermatitis

Conditions: Pruritus; Atopic Dermatitis

Summary: study of the efficacy, safety, and tolerability of serlopitant for pruritus (itch) in atopic dermatitis

this is a double-blind, randomized, placebo-controlled study. approximately 450 subjects will be randomized in a 1:1:1 ratio to receive daily oral doses of serlopitant 1 mg, 5 mg, or placebo for 6 weeks. during the screening period, subjects will be provided with an electronic device for recording electronic diary (ediary) assessments throughout the study. this ediary will be used to capture efficacy endpoint data and treatment information. at the baseline visit, eligible subjects will be randomized, and study drug dispensed beginning with a loading dose of 3 tablets to be taken at bedtime that same day. starting on study day 2, subjects will take one tablet per day at bedtime. treatment will continue for 6 weeks. the primary efficacy endpoint will be assessed during week 6. after completion of the 6-week treatment period, all subjects will enter a 4-week follow-up period.

Eligibility criteria:
inclusion criteria: * male or female, age 13 years or older * pruritus prior to and during the initial screening period * diagnosis of atopic dermatitis * judged to be in good health in the investigator's opinion exclusion criteria: * prior treatment with study drug or similar drug * pruritus due to another reason besides atopic dermatitis * presence of any medical condition or disability that could interfere with study * history of hypersensitivity to serlopitant or any of its components * currently pregnant or male partner of pregnant female * females of childbearing potential who are unable or unwilling to use adequate contraception or who are breast feeding
randall's plaque study: pathogenesis and relationship to nephrolithiasis

Conditions: Nephrocalcinosis; Renal Calculi; Hypercalciuria; Hyperparathyroidism; Cystinuria

Summary: kidney stones are very common. they affect 3-5% of the population in the united states. many people are hospitalized for the treatment of kidney stones and some may die. better understanding of what causes kidney stones is useful in both the treatment and prevention of kidney stones. however, exactly what causes kidney stones is unknown. the most common type of kidney stones contains calcium, which sometimes is attached to a part of the kidney important in producing the final urine, called the papilla. the investigators have noticed that persons who form kidney stones seem to have more papilla with stones attached. they propose to study these areas of the papilla, called randall's plaques (named after their discoverer), in patients undergoing surgery for kidney stones.

in order to attempt to explain the pathogenesis of renal calculi, the investigators videotape and document the location and characteristics of each stone, papillae and calyces. one or more small papillary biopsies are taken for analysis to help determine the point of origin of the kidney stone and histological studies are undertaken to determine tissue differences amongst different types of stone formers. approximately one month after surgery, metabolic studies are undertaken to further review potential causes of stone formation.

Eligibility criteria:
inclusion criteria: * patients of methodist urology in indianapolis, in who are undergoing endoscopic procedures for nephrolithiasis or other urologic disease. * upper urinary tract endoscopic or perc procedure for kidney stones removal * general medical health allowing surgical procedure * ability to complete all the necessary components of the study * able to sign an informed consent exclusion criteria: * poor general medical health * bleeding diathesis * inability or unwillingness to comply with post-surgical follow-up

Keywords: randall's plaque kidney stones
modified ketogenic diet in patients with mcardle disease part a

Conditions: McArdle Disease

Summary: mcardle disease, glycogen storage disease type v, is a rare metabolic disease. affected individuals are unable to utilize sugar stored as glycogen in muscle. we hypothesize that a modified ketogenic diet could be a potential treatment option, by providing ketones as alternative fuel substrates for working muscle. in this open interventional pilot study we wish to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet that ensures adequate degree of ketosis and at the same time is well tolerated for patients with mcardle disease.

open interventional study to investigate 3 different modified ketogenic diet regimes, to find an optimal composition of a modified ketogenic diet for patients with mcardle disease mcardle disease, glycogen storage disease type v, is a rare metabolic disease caused by mutations in the pygm gene resulting in absence of the enzyme muscle phosphorylase. affected individuals are unable to utilize sugar stored as glycogen in muscle, leading to exercise intolerance, exercise-induced muscle pain, contractures and rhabdomyolysis, which may cause renal failure. currently, there are no satisfactory treatment options for mcardle disease. ketones are feasible fuel alternatives to muscle glycogen when muscle glycogenolysis is blocked as in mcardle disease. a key element of alleviating symptoms in mcardle disease is to provide alternative fuels for energy metabolism. ketosis can potentially provide alternative fuel substrates by provision of endogenous ketone bodies (kbs) which are desirable fuels for skeletal muscle and brain. ketosis can be reached by fasting and can be induced by adhering to a modified ketogenic diet, which entails a high-fat, low-carbohydrate diet, which simulates the metabolic effects of fasting. the optimal modified ketogenic diet composition, that ensures adequate degree of ketosis and at the same time is well tolerated, has not been investigated in patients with mcardle disease. therefore this pilot study seeks to investigate which of 3 different diets is the most optimal ad effective for patients with mcardle disease. the 3 different diets will have carbohydrate percentages ranging from 5-25%, and fat percentage from 60-80%.

Eligibility criteria:
inclusion criteria: * genetically confirmed gsdv * patient is willing and able to provide written informed consent prior to participation. * patient is ambulatory. * women in fertile age must be willing to practice the following medically acceptable methods of birth control exclusion criteria: * patient has any prior or current medical conditions that, in the judgment of the investigator, would prevent the patient from safely participating in and/or completing all study requirements. * pregnancy or breastfeeding * patient does not have the cognitive capacity to understand/comprehend and complete all study assessments * patients with porphyria or disorders of fat metabolism (primary carnitine deficiency, carnitine palmitoyltransferase i or ii, β-oxidation defects etc.).
study of virus-specific lymphocytic cell populations in non-invasive nasal mucosa samples of mis-c patients

Conditions: MIS-C Associated With COVID-19; COVID-19

Summary: the aim of the study is to make an accurate assessment of immune cells obtained from nasal mucosa and peripherial blood of mis-c patients during the disease and the period of health.

the study will consist of two parts. initially, it will be of a cross-cutting comparative nature, when a group of healthy patients (control group) and a group of patients diagnosed with mis-c/pims syndrome are compared with each other, based on nasal curettage swabs and peripheral blood, before the inclusion of systemic anti-inflammatory treatment (study group). in addition, an observation of the research group will be carried out, during which swabs and peripheral blood will be taken at two more control points.

Eligibility criteria:
inclusion criteria: * mis-c diagnosis based of who diagnostic criteria. exclusion criteria: * immunosuppressive treatment received up to 3 months before * intranasal drugs received up to 7 days before * covid-19 vaccination * no consent

Keywords: leukocytes immunophenotype nasal mucosa curettage
identification of predictive neuroinflammatory biomarkers of neuro-radiological evolution in severe traumatic brain injury

Conditions: Severe Traumatic Brain Injury

Summary: tertiary lesions responsible of the neurological decline after severe traumatic brain injury (tbi) are partially due to a persistent neuro-inflammation directly modulated by inflammatory mediators during the acute phase and detectable by using both multimodal mri imaging and biological biomarkers during the acute phase after traumatic brain injury. the main objective is to identify if the level of il-1beta in cerebrospinal fluid predict in a reliable and reproducible way, the neuro-radiological evolution evaluated by the comparison of a quantitative mri performed in post-resuscitation and at one year (quantitative δirm) in traumatic brain injuried patients. the secondary objectives are: * to understand the links between the acute and chronic neuro-inflammatory phase in a population of tbi, * to explore the contribution of the adaptive immune response in the persistent activation of the immune response, * to examine the links between persistent neuroinflammation, clinical deterioration and neuroimaging, * to establish a correlation between the pathology and the physio-pathology of tbi.


Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years old at the time of inclusion 2. written and informed consent obtained from the family / proxy 3. patient hospitalized in neuro-icu following severe tbi with gcs ≤ 8 at admission 4. intubated / ventilated patient scheduled for external ventricular bypass within 24 hours of hospitalization 5. absence of contraindications to perform an mri 6. patient affiliated to a social security scheme (free state medical aid excluded) exclusion criteria: 1. patient under protection of the law (guardianship or tutorship) 2. tbi of ballistic origin 3. pregnant woman 4. pre-existing cerebral disease that can bias the mri scan evaluation 5. contraindications to the mri (pace maker, medical device incompatible with mri, metal plates, ...) 6. patient with severe impairment of vital and / or life-threatening function with disability prior tbi 7. neurological antecedent susceptible to interfere with clinical evolution at one year 8. severe cardiogenic shock 9. severe respiratory impairment 10. extra-brain injuries involving immediate life-threatening 11. hemoglobin level below 9g / dl

Keywords: inflammatory biomarkers, traumatic brain injury, multimodal mri, tertiary lesion
clinical study to evaluate the efficacy and safety of dermalax implant plus

Conditions: Correction of Nasolabial Folds

Summary: this study is to verify that dermalax implant plus is not inferior to the reference device, restylane® sub-q, in terms of efficacy and safety in the correction of nasolabial folds


Eligibility criteria:
inclusion criteria: 1. male or female subjects no younger than 30 and no more than 75 years of age. 2. subjects who scored 3 or 4 on the wrinkle severity rating scale (wsrs) and want to improve the appearance of their nasolabial folds (the subject does not need to have the same score on both sides.\*) \*the scores need not to be same on both sides, but the two nasolabial folds should have symmetry in the range of 3-4. 3. subjects who have symmetric nasolabial folds. exclusion criteria: 1. subjects who received an antithrombotic agent within 2 weeks prior to screening (with the exception of low dose aspirin less than 300 mg/day) 2. subjects who have a history of bleeding disorder. 3. subjects who have received calcium hydroxyapatite, caha injection in nasolabial area.
symfony intraocular lens retrospective chart review

Conditions: Cataract

Summary: retrospective chart review of patients with pre-existing ocular pathology who underwent cataract surgery with implantation of the symfony iol.

this was a retrospective chart review conducted at a single us clinical site. chart review was conducted by john odette, md and research assistants. eligible charts were identified via a clinic database search of cataract surgeries with iol implantation of the symfony iol during the stated date range. eligible charts included those of patients 18 to 90 years of age who underwent femto laser assisted cataract surgery (flacs) with implantation of a symfony iol. charts were excluded for lack of postoperative follow-up or if symfony iol was not implanted. all qualifying patient charts were examined and further classified into 2 groups: (1) eyes with glaucoma; and 2) eyes without glaucoma. visual acuity was evaluated for patients who underwent cataract surgery with implantation of the symfony iol from 09/1/2016 to 05/31/2018. postoperative evaluations at month 2 included mean monocular uncorrected visual acuity at near (unva) at 40 cm, far distance (udva) at 20 ft, and with best correction (cdva). outcomes were also compared for toric iols versus spherical iol.

Eligibility criteria:
inclusion criteria: * :phacoemulsification cataract surgery with a symfony iol. exclusion criteria: * : eyes not implanted with a symfony iol or unstable refractive results at final post-operative visit

Keywords: cataract surgery glaucoma retinopathy intraocular lens
tandem control-iq evaluation regarding glucose metrics, sleep, and health economics

Conditions: Type 1 Diabetes

Summary: to evaluate tandem control-iq compared with rtcgm and insulin pen respectively rtcgm and insulin pump treatment in children and adolescents regarding glucose control, sleep and health economics for 18 months.

in this obesrvational study, the investigators assessed glycemic outcomes, sleep and health economics associated with aid treatment (tandem control-iq) compared with multiple daily insulin injections with rtcgm (mdi+rtcgm) and a standalone insulin pump with rtcgm (csii+rtcgm). participants from two clinical sites in sweden who continuously used one of the three modalities for at least six months were included in the analysis. inclusion required all participants to use the dexcom g6 rtcgm sensor for glucose monitoring, which meant only insulin treatment differentiated the three groups. comparisons were conducted regarding hemoglobon a1c (hba1c) at the start of the study and rtcgm-generated glycemic metrics from 1 month before the study started until 18 months. sleep quality and quantity were assessed using a questionnaire for the persons with diabetes and the caretakers. indirect and direct costs in all healthcare systems and additional information on sick leaves were collected from the swedish social insurance agency. comparisons were then made between the three treatment alternatives.

Eligibility criteria:
inclusion criteria: * age between 2-19 years at the start * diagnosed with type 1 diabetes * min duration three months * willingness to participate in the study exclusion criteria: * pregnancy * unwillingness to share and upload cgm data * reluctance to come to visit and to follow protocol * history of allergic reaction to dexcom cgm materials or adhesives in contact with the skin. * abnormal skin at the anticipated glucose sensor attachment sites(excessive hair, burn, inflammation, infection, rash, and/or tattoo)
eplbd with limited est vs. eplbd for choledocholithiasis

Conditions: Choledocholithiasis

Summary: endoscopic papillary balloon dilation (epbd) for choledocholithiasis is known to be comparable to endoscopic sphincterotomy (est) especially in cases of small stones. with larger stones (\> 10 mm), epbd with conventional balloon, which have a diameter of 6-8 mm, was reported as less effective for extraction of stones, requiring additional mechanical lithotripsy (ml). the present study aims to compare the efficacy and safety of limited est plus endoscopic papillary balloon dilation (est-epbd) with endoscopic papillary large balloon dilation for large choledocholithiasis.

ercp is the best option to remove bile duct stones. it can be done by either endoscopic sphincterotomy (est) or endoscopic papillary balloon dilation (epbd). large bile duct stones appear to be more difficult to remove with conventional methods, such as est and epbd. therefore, extraction of large bile duct stones may require mechanical lithotripsy (ml) as an adjunctive procedure. the primary complication of ml is basket and stone impaction, which can lead to complications such as pancreatitis and cholangitis. some recent studies have reported the efficacy of endoscopic papillary large balloon dilation (eplbd) alone or combined with limited est, establishing it as a safe treatment for the removal of large bile duct stones. the investigators conducted the present study to compare the therapeutic outcome and complications between eplbd alone and limited est plus eplbd for the treatment of large bile duct stones.

Eligibility criteria:
inclusion criteria: * large bile duct stones (≥10 mm) exclusion criteria: * pregnancy * refusal of written informed consent * patients with benign or malignant biliary stricture * contraindications to ercp exist * complicated with acute pancreatitis or acute cholangitis * coagulation dysfunction，thrombocytopenia * prior est or epbd * patients after gastrointestinal reconstruction

Keywords: endoscopic sphincterotomy endoscopic papillary balloon dilation complication safety choledocholithiasis
a study of herceptin (trastuzumab) in combination chemotherapy in women with locally advanced breast cancer

Conditions: Breast Cancer

Summary: this study will assess the efficacy and safety of adding herceptin to a paclitaxel-containing regimen followed by cyclophosphamide/methotrexate/fluorouracil (cmf) chemotherapy in women with locally advanced breast cancer and her2/c-erbb-2 gene amplification. in a parallel observational study patients with her2-negative disease will receive the same chemotherapy without herceptin.


Eligibility criteria:
inclusion criteria: * female patients, \>=18 years of age, with locally advanced breast cancer. exclusion criteria: * previous therapy for any invasive malignancy.
a phase ii study to evaluate the safety and efficacy of tqb2450 injection in relapsed or refractory classical hodgkin's lymphoma

Conditions: Safety and Effectiveness

Summary: single-arm, open-label, multicenter clinical trial. to observe the efficacy and safety of tqb2450 in patients of non-hodgkin lymphoma


Eligibility criteria:
inclusion criteria: 1. subject has voluntarily agreed to participate by giving written informed consent.; 2. histopathological confirmed classical hodgkin's lymphoma; 3. relapsed/refractory chl include：a)subject with relapse and progression after salvage chemotherapy followed by autologous stem cell transplantation(asct); b) subject with no asct: the first-line chemotherapy must be systemic multi-drug combination chemotherapy and subsequent chemotherapy requires at least one first-line chemotherapy must be systemic multi-drug combination chemotherapy; subject which is refractory didn't achieve pr after 2 cycles or didn't achieve cr after 4. age ranged from 18 to 75 years; 5. at least one measurable disease ; 6. patients must have ecog performance status of 0-2; 7. subject must have adequate organ functions ：count of blood cells:hemoglobin content(hb)≥80g/l; absolute neutrophil count (anc) ≥ 1.0 × 10\^9 / l; platelet count (plt) ≥ 75 × 10\^9 / l;; biochemical examination: serum total bilirubin (tbil) ≤ 1.5 × normal upper limit (uln), with the exception of patients with hepatic metastases and gilbert's syndrome(tbil≤3×uln） ; alanine aminotransferase (alt) and aspartate aminotransferase (ast) ≤ 3 × uln，with the exception of patients with hepatic metastases (alt and ast ≤ 5 × uln) , serum creatinine (cr) ≤ 1.5 × uln or creatinine clearance rate（ccr）≥50 ml/min；serum amylase and lipase ≤ 1.5 x uln blood coagulation function:international standardized ratio(inr)≤1.5×uln、activation partial thrombin time(aptt)≤1.5×uln、prothrombin time≤1.5×uln；doppler ultrasound evaluation：left ventricular ejection fraction（lvef)≥50%×mln; exclusion criteria: * 1、nodular lymphocyte-predominant hodgkin lymphoma or gray zone lymphoma； 2、 prior exposure to any anti-pd-1, anti-pd-l1 ， anti-ctla-4 antibody or car-t cell treatment(any other antibody that has been applied to a t cell synergistic stimulus or checkpoint pathway); 3、need to therapy with other anticancer during the study; 4、received allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
correlation between vitamin d status and bone mineral density in patients with hemophilia

Conditions: Hemophilia A; Hemophilia B; Vitamin D Deficiency

Summary: study will look at baseline vitamin d levels, calcium, albumin, liver enzymes, testosterone, osteocalcin, urine n telopeptides, bone mineral density, nutritional assessment and physical activity assessment of boys with hemophilia a or b (ages 2-20 yrs). patients with low vitamin d levels will receive therapeutic doses of vitamin d. at end of one year follow up studies will be repeated.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of hemophilia a or b * ages 2-21 years exclusion criteria: * therapeutic vitamin d or calcium supplementation within 3 months of study entry

Keywords: hemophilia vitamin d